Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion

This study has been completed.
Sponsor:
Collaborator:
W.L.Gore & Associates
Information provided by:
Texas Vascular Associates
ClinicalTrials.gov Identifier:
NCT00962897
First received: August 19, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.


Condition Intervention
Atherosclerosis
Lower Extremity Ischemia
Claudication
Rest Pain
Procedure: Femoral-popliteal bypass
Procedure: Stent-graft placement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Review of Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion With Four Years Followup

Resource links provided by NLM:


Further study details as provided by Texas Vascular Associates:

Primary Outcome Measures:
  • Primary artery/graft patency [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary artery/graft patency [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Limb salvage [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Improvement of lower extremity ischemic symptoms [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: September 2003
Study Completion Date: July 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical Bypass Group
Those patients that underwent bypass of blockage in the thigh with surgery.
Procedure: Femoral-popliteal bypass
Surgical bypass of blockage in the thigh
Stent-graft group
Patients that underwent treatment of blockage in the thigh with balloon angioplasty and stent placement.
Procedure: Stent-graft placement
Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Vascular surgery clinic patients with ischemic symtpom of the lower extremities. Patients were previously enrolled in a randomized prospective study comparing treatment of blockage in the legs with a surgical bypass or percutaneous covered stent placemnt.

Criteria

Inclusion Criteria:

  • Symptomatic lower extremity ischemia patients treated by femoral-popliteal bypass or percutaneous covered stent graft in previous prospective study

Exclusion Criteria:

  • NA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962897

Locations
United States, Texas
Texas Vascular Associates
Dallas, Texas, United States, 75226
Sponsors and Collaborators
Texas Vascular Associates
W.L.Gore & Associates
Investigators
Principal Investigator: Dennis R Gable, M.D. Texas Vascular Associates
  More Information

Publications:
Responsible Party: Dennis Gable, MD, Texas Vascular Associates/Baylor University Medical Center
ClinicalTrials.gov Identifier: NCT00962897     History of Changes
Other Study ID Numbers: 009-198, Viabahn #2
Study First Received: August 19, 2009
Last Updated: August 19, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Texas Vascular Associates:
atherosclerosis
covered stent
percutaneous intervention
stent
angioplasty

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014